Global Patient Recruitment Translation Services
Expert Multilingual Support for Patient Recruitment in Clinical Trials and Drug Development. Stepes (/’steps/) provides expert language translation services for international patient recruitment in over 100 languages.
Accurate Patient Recruitment Translations You Can Trust
Are you a pharmaceutical company, contract research organization (CRO), medical device manufacturer, or biotechnology firm in need of professional language translation services to support international patient recruitment and patient diversity programs for clinical trials? Look no further than Stepes. We possess the linguistic resources, clinical localization expertise, and state-of-the-art language technologies needed to translate informed consent forms, recruitment materials, and patient diaries with the highest quality and efficiency.
Stepes leverages cutting-edge translation memory tools and terminology management systems to ensure consistency and accuracy across all clinical translation requirements, including linguistic validation, forward translation, and back translation. Our intelligent, cloud-based language management platform supports real-time translation progress tracking and integrates seamlessly with client systems, facilitating swift updates and iterative revisions necessary for multi-phase clinical trials. Furthermore, our network of certified medical translators, who specialize in over 100 languages, enables Stepes to deliver precise translations that meet the stringent regulatory standards of global health authorities, significantly contributing to the success and integrity of international clinical trials.
Explore Our Patient Recruitment Translation Project Examples
For international patient recruitment in clinical trials, the translation of various documents is crucial to ensure clear communication and regulatory compliance across different languages and cultures. Accurate translations help ensure compliance with FDA and local regulations and play a crucial role in maintaining patient diversity, respecting the linguistic and cultural nuances of each participant group. Stepes brings extensive experience to the translation of key patient recruitment documents, ensuring precision and cultural sensitivity in every project.
INFORMED CONSENT FORM
Clinical Trial Title: Evaluation of Efficacy and Safety of CompX in Patients with Chronic Pain
Protocol Number: CPX-2024-03
Principal Investigator: Dr. Jane Smith, MD
Trial Site: Springfield Medical Research Institute
Sponsor: Global Pharma Inc.
Note: This sample Informed Consent Form is fictitious and provided for illustration purposes only.
Introduction
This Informed Consent Form (ICF) is designed to provide you with the information necessary to make an informed decision about your participation in this clinical trial. The trial involves a new medication, CompX, intended for the treatment of chronic pain. This document details the purpose, procedures, potential benefits, and risks associated with the trial. Please read this form carefully and ask any questions you may have before agreeing to participate.
Purpose of the Study
The purpose of this clinical trial is to assess the efficacy and safety of CompX in reducing symptoms of chronic pain in adults. This study will compare the effects of CompX with a placebo to determine if CompX is more effective in managing pain symptoms.
Participant Eligibility
Eligible participants are adults aged 18-65 who have been diagnosed with chronic pain and have experienced symptoms for at least six months.
Study Procedures
If you agree to participate in this trial, you will be randomly assigned to receive either CompX or a placebo. Neither you nor the study staff will know which treatment you are receiving (double-blind study). The trial will last for 12 months, during which you will:
- Visit the trial site approximately once a month for health assessments.
- Receive the study medication or placebo at no cost.
- Complete regular questionnaires about your pain levels and any side effects.
Potential Benefits
While there is no guarantee of personal benefit, the information obtained from this study may help develop a more effective treatment for chronic pain.
Potential Risks and Discomforts
Possible risks associated with CompX include nausea, headaches, and dizziness. There is also the potential for more serious side effects, which will be monitored closely throughout the trial.
Confidentiality
Your medical information obtained in this study is confidential and will be disclosed only with your permission or as required by law. Data from this trial may be published, but your identity will not be disclosed in any reports.
Voluntary Participation
Your participation in this trial is entirely voluntary. You may withdraw at any time without penalty or loss of benefits to which you are otherwise entitled.
Compensation
Participants will receive $500 upon completion of the trial to compensate for time and travel expenses.
Contact Information
For any questions or concerns about the study or your rights as a participant, please contact the study coordinator at (123) 456-7890 or studycoordinator@springfieldresearch.com.
Consent
I have read this Informed Consent Form and have had the opportunity to ask questions. I understand the risks and benefits involved and agree to participate in this clinical trial.
Participant Name: __________________________________
Participant Signature: _______________________________
Date: _____________________________________________
Request Translated Versions
To ensure all participants can fully comprehend the details of the clinical trial, translated versions of this Informed Consent Form (ICF) are available upon request. Please specify your language preference by contacting us here, and we will provide you with a professionally translated document to facilitate informed decision-making. This service underscores our commitment to inclusivity and accessibility in clinical trials.
Below is a list of languages into which Stepes frequently translates ICFs:
- Spanish
- Chinese (Simplified)
- Russian
- Portuguese
- French
- Arabic
- German
- Japanese
- Korean
- Hindi
Patient Information Leaflet (PIL)
Title of Clinical Trial:
Evaluation of the Efficacy and Safety of Drug X in Patients with Moderate to Severe Chronic Pain
Sponsor:
Global Pharma Corp.
Protocol Number:
GPC/CP2024/01
Version:
1.2
Date:
August 9, 2024
Disclaimer: This document is a sample and is provided for illustrative purposes only.
Introduction
This Patient Information Leaflet (PIL) provides you with important information about the clinical trial for Drug X. Please read this leaflet carefully before deciding to participate in the trial. It contains essential information about the purpose of the study, what it will involve for you, the benefits, risks, and your rights as a participant.
What is the purpose of the study?
The purpose of this clinical trial is to evaluate the efficacy and safety of Drug X in treating moderate to severe chronic pain. The results will help determine whether Drug X is an effective and safe treatment option for patients with this condition.
Who can participate in the study?
Participants must meet the following criteria:
- Aged 18 to 65 years.
- Diagnosed with moderate to severe chronic pain for at least six months.
- Not currently participating in other clinical trials.
What does the study involve?
If you agree to participate, here is what the process will look like:
- Initial Consultation: You will undergo a thorough medical examination to confirm your eligibility.
- Treatment Phase: You will receive either Drug X or a placebo, as randomly assigned, to be taken daily for 12 weeks.
- Monitoring: Regular follow-up visits will be scheduled every two weeks to monitor your health and any side effects.
- Feedback: You will be asked to keep a diary of your pain levels and any side effects experienced during the study.
What are the possible benefits?
Participants may experience an improvement in pain management. Additionally, all participants will receive health monitoring throughout the study.
What are the potential risks?
While taking Drug X, some participants may experience side effects such as nausea, dizziness, or headaches. All potential risks will be monitored closely by the study team.
Confidentiality
Your personal data and medical information obtained during this study will remain confidential and will only be shared with health professionals directly involved in the trial.
Your rights as a participant
- You can withdraw from the study at any time without any consequences.
- You will not lose any medical benefits to which you are otherwise entitled.
If you are interested in participating or have any questions, please contact the study coordinator at:
- Phone: +1 800 xxx xxxx
- Email: studycoordinator@globalpharmaxxx.com
Thank you for considering participation in our clinical trial. Your involvement is invaluable in advancing medical research and potential treatment options.
Request Translated Versions
To request translated versions of the sample Patient Information Leaflet (PIL) to evaluate Stepes' language translation quality for multilingual patient recruitment, please contact us here. Our expertise in delivering technically accurate and culturally competent translations ensures the highest quality communications for your clinical trials.
Below is a list of languages into which Stepes frequently translates PILs:
- Spanish
- Chinese (Simplified)
- Russian
- Portuguese
- French
- Arabic
- German
- Japanese
- Korean
- Hindi
Clinical Trial Protocol
Title of Study:
Evaluation of Efficacy and Safety of Compound X in Patients with Advanced Melanoma
Protocol Number:
CMPX-2024-MEL01
Version Number:
1.2
Date:
August 7, 2024
Sponsor:
Global BioPharma Inc.
Principal Investigator:
Dr. John Doe, MD
Study Sites:
Springfield Clinical Research Center
Riverdale Medical Institute
Contact Information:
Clinical Trials Office
Global BioPharma Inc.
Phone: +1 800 xxx xxxx
Email: CMPX-MEL01@globalbiopharmaxxx.com
Disclaimer: This document is a sample and is provided for illustrative purposes only.
- Background and Rationale
- Trial Objectives
Primary Objective:
To assess the efficacy of Compound X in improving survival rates among patients with advanced melanoma.
Secondary Objectives:
- To evaluate the safety profile of Compound X in the study population.
- To determine the impact of Compound X on quality of life and disease progression.
- To collect pharmacokinetic (PK) and pharmacodynamic (PD) data of Compound X in the treated population.
- Study Design
Type of Study:
This is a Phase III, randomized, double-blind, placebo-controlled trial.
Study Population:
Adult patients aged 18 to 75 years diagnosed with advanced melanoma.
Inclusion Criteria:
- Confirmed diagnosis of advanced melanoma (Stage III or IV).
- No prior chemotherapy or targeted therapy within the last 4 weeks.
- Adequate organ function as measured by standard laboratory tests.
Exclusion Criteria:
- History of other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal/squamous cell carcinoma of the skin.
- Active, known or suspected autoimmune disease.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Intervention:
Participants will be randomly assigned to receive either Compound X or a placebo. The treatment will be administered intravenously once every two weeks for up to 24 weeks.
Duration of Study:
Approximately 18 months including a 6-month follow-up period to assess long-term effects and outcomes.
Endpoints:
- Primary Endpoint: Overall survival at 12 months.
- Secondary Endpoints: Incidence of treatment-emergent adverse events, changes in quality of life scores from baseline at 6 and 12 months, and PK/PD profiles.
Request Translated Versions
To evaluate the quality of Stepes' language translation services for multilingual patient recruitment, we invite you to request translated versions of the sample Clinical Trial Protocol here. Our expertise in delivering technically accurate and culturally competent translations ensures the highest quality communications for your clinical trial patient recruitment efforts.
Below is a list of available languages for translation:
- Spanish
- Chinese (Simplified)
- Russian
- Portuguese
- French
- Arabic
- German
- Japanese
- Korean
- Hindi
Clinical Trial Translation
Patient recruitment translation is an integral part of Stepes’ professional clinical trial translation solutions. We have in-depth experience translating key documents essential for the success of clinical trials. This includes Clinical Outcome Assessments (COAs), which measure the impact of a drug or device on disease symptoms, functioning, and overall quality of life as reported by the patient. We also translate clinical trial protocols, detailing the study’s design, methodologies, and statistical considerations. Additionally, our expertise extends to case report forms, which are crucial for accurate data collection and record-keeping from clinical trial sites. To learn more about Stepes’ expert clinical translation services, please click here.
Linguistic Validation
Linguistic validation is an important methodology used in clinical trial translations, particularly for patient-reported outcomes (PROs), Clinician-Reported Outcomes (ClinROs), and other assessment tools that measure health-related quality of life, symptoms, or treatment efficacy across different languages. At Stepes, we handle all of the following translation-related methods that are commonly employed in patient recruitment translations and clinical trial translations to ensure accuracy, compliance, and effectiveness:
- Back Translation: This is a process where a translated document is independently translated back into the original language by a different translator. This helps to verify the accuracy and appropriateness of the initial translation. Stepes utilizes back translation extensively in clinical trials to ensure that the translated content precisely reflects the original text’s meaning and intent.
- Reconciliation: Following back translation, reconciliation is performed by Stepes to resolve any discrepancies between the original document and the back-translated version. This step involves a thorough review by a third party, typically a subject matter expert or a senior translator at Stepes, to ensure that the translation is both accurate and culturally appropriate.
- Cognitive Debriefing: This involves testing the translated documents with a target audience—often through interviews or focus groups—to ensure that the translations are understandable and culturally relevant. Stepes conducts cognitive debriefing to assess whether the translation effectively communicates the necessary information to potential trial participants in a way that is easy to understand and accept.
- Harmonization: In multi-country trials, Stepes ensures consistency across various translations. This process involves aligning the translations in different languages to maintain the uniformity of the content and ensure that all regulatory and cultural nuances are appropriately addressed across all versions.
- Proofreading and Editing: After the initial translation, documents undergo rigorous proofreading and editing by native speakers at Stepes to correct any linguistic, grammatical, or typographical errors. This step is crucial for maintaining the professional quality of the documents and ensuring that they meet the high standards required in clinical trials.
- Desktop Publishing and Formatting: Translated documents often require professional desktop publishing services by Stepes to ensure that the layout and formatting of the translated documents match the original. This is particularly important for printed materials, such as informed consent forms and patient information leaflets, where the visual presentation can impact readability and comprehension.
- Regulatory Review: Depending on the countries involved, translated clinical trial documents handled by Stepes may need to undergo a regulatory review to ensure compliance with local laws and guidelines. This can include reviews by local health authorities or ethics committees.
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